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Here are the latest China NMPA Regulatory and Clinical Affairs news for medical device and IVDs pros for July 2022. These updates are presented by China Med Device, LLC, your
The NMPA granted Innovation Approvals to the following devices in July 2022: Cardiovascular Transcatheter prosthetic pulmonary valve system Implantable left ventricular assist system Radiology Gamma beam stereotactic radiation therapy system
The NMPA issued the “Guideline on Instructions for Use of In Vitro Diagnostic Reagents (draft)” for feedback. The guideline stipulates drug information such as the intended use, test methods, interpretation
The NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on July 14, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison
The NMPA published eighteen industry recommended standards on July 6, 2022 to guide manufacturers for local type testing and regulatory approval: YY/T 0273-2022 Dentistry-Dental amalgam blender YY/T 0290.4-2022 Ophthalmic optics
The NMPA released the “Guideline for Fundamental Principles Compliance of Medical Device Safety and Performance”, elaborating the risk-based approach for medical device registration review. Article 13 of “Administrative Measures for
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in June 2022. These updates are presented by China Med Device, LLC, your partner
The NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022. Among them, 16 devices are applied in cosmetic surgery. From April
The NMPA published the draft version of “Clinical Trial Exemptions Catalog for Medical Devices” on July 5, 2022, for feedback. It is an effort to implement risk-based clinical evaluation, and
Here’s the latest China NMPA regulatory and clinical affairs news roundup for medical device and IVDs pros in May 2022. These updates are presented by China Med Device, LLC, your
The NMPA published “Implementation Plan for Supporting Hong Kong and Macao Drug Market Authorization Holders to Produce Drugs and Medical Devices in 9 Mainland Cities in the Greater Bay Area
The NMPA published the “2021 Medical Device Guidelines Revisions Plan” on June 23, 2022, in which 75 guidelines are affected. The revisions are aimed to facilitate manufacturers with local type